A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076
LEOPARD
An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects With Overactive Bladder (OAB)
2 other identifiers
interventional
148
15 countries
37
Brief Summary
This was a 40-week study to investigate how safe and effective solifenacin solution was in treating children or adolescents with symptoms of overactive bladder (OAB), who completed study 905-CL-076 (NCT01565707).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2012
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2012
CompletedFirst Posted
Study publicly available on registry
August 1, 2012
CompletedStudy Start
First participant enrolled
October 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2014
CompletedResults Posted
Study results publicly available
December 11, 2017
CompletedNovember 13, 2024
October 1, 2024
2 years
July 30, 2012
June 28, 2017
October 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs)
The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affect normal daily activities; Severe: Inability to perform daily activities. In participants treated with placebo in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of open-label solifenacin in Study 905-CL-077 up to 7 days after the last dose of solifenacin. In participants treated with solifenacin in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of double-blind solifenacin in Study 905-CL-076 up to 7 days after last dose of open-label solifenacin in Study 905-CL-077.
From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076).
Secondary Outcomes (5)
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days
Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Change From Baseline in Mean Number of Micturitions Per 24 Hours
Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents
Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume
Baseline (of 905-CL-076 study) to final Visit (the most recent value after first dose of solifenacin up to 40 weeks for participants who received placebo in 076 and 52 weeks for those who received solifenacin in 076.)
Study Arms (4)
Children Treated with Placebo in 905-CL-076
EXPERIMENTALMale and female children aged 5 to less than 12 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.
Children Treated with Solifenacin in 905-CL-076
EXPERIMENTALMale and female children aged 5 to less than 12 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.
Adolescents Treated with Placebo in 905-CL-076
EXPERIMENTALMale and female adolescents aged 12 to less than 18 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.
Adolescents Treated with Solifenacin in 905-CL-076
EXPERIMENTALMale and female adolescents aged 12 to less than 18 years old who received solifenacin in Study 905- CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.
Interventions
Oral suspension
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Site: 1006
Shreveport, Louisiana, 71106, United States
Site: 3202
Antwerp, 2020, Belgium
Site: 3209
Antwerp, 2650, Belgium
Site: 3208
Charleroi, 6000, Belgium
Site: 3201
Ghent, 9000, Belgium
Site: 3203
Ghent, 9000, Belgium
Site: 3204
Kortrijk, 8500, Belgium
Site: 3205
Leuven, 3000, Belgium
Site: 5507
Campinas, 13087-567, Brazil
Site: 5506
Curitiba, 80240-060, Brazil
Site: 1001
Québec, G1V 4G2, Canada
Site: 4503
Aalborg, DK-9000, Denmark
Site: 4501
Aarhus N, 8200, Denmark
Site: 4502
Kolding, 6000, Denmark
Site: 4504
Køge, 4600, Denmark
Site: 5202
Mexico City, 4530, Mexico
Site: 5205
Mexico City, C.P.06700, Mexico
Site: 4701
Bergen, 5021, Norway
Site: 6301
Quezon City, 1108, Philippines
Site: 4805
Gdansk, 80-803, Poland
Site: 4803
Gdansk, 80-952, Poland
Site: 4804
Lubin, 20-093, Poland
Site: 4801
Warsaw, 04-736, Poland
Site: 3810
Belgrade, 11 000, Serbia and Montenegro
Site: 3812
Novi Sad, 21000, Serbia and Montenegro
Site: 2703
Cape Town, 7700, South Africa
Site: 8203
Daegu, 705717, South Korea
Site: 8206
Incheon, 400-711, South Korea
Site: 8207
Seoul, 110744, South Korea
Site: 8202
Seoul, 156707, South Korea
Site: 4606
Gothenburg, 41685, Sweden
Site: 4603
Skövde, 54185, Sweden
Site: 4602
Stockholm, 11883, Sweden
Site: 4605
Umeå, 90185, Sweden
Site: 9001
Ankara, 6100, Turkey (Türkiye)
Site: 9002
Izmir, 35100, Turkey (Türkiye)
Site: 3854
Kharkiv, Ukraine
Site: 4403
Leeds, LS1 3EX, United Kingdom
Site: 4401
Sheffield, S10 2TH, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Astellas Pharma Europe B.V.
Study Officials
- STUDY CHAIR
Clinical Study Manager
Astellas Pharma Europe B.V.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2012
First Posted
August 1, 2012
Study Start
October 4, 2012
Primary Completion
October 8, 2014
Study Completion
October 8, 2014
Last Updated
November 13, 2024
Results First Posted
December 11, 2017
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.